Plaxtron Industrial (M) Sdn. Bhd.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Plaxtron Industrial (M) Sdn. Bhd. makes
Plaxtron Industrial manufactures suction units, including the PLAXTRON SUCTION UNIT (Model 88AA51/88AA61 Series), designed for medical and industrial applications requiring efficient fluid removal.
The company’s portfolio is regulated under Class II devices in the US, with relevant products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Plaxtron Industrial (M) Sdn. Bhd. IPOH Perak · MY FEI 1000283452
Frequently asked questions
How many devices does Plaxtron Industrial (M) Sdn. Bhd. have in the registry?
The registry currently lists 1 device for Plaxtron Industrial (M) Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Plaxtron Industrial (M) Sdn. Bhd.'s devices?
Among its 1 most recently registered device, Plaxtron Industrial (M) Sdn. Bhd. has devices listed in FDA 510(k) (1 device).
What risk classes do Plaxtron Industrial (M) Sdn. Bhd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Plaxtron Industrial (M) Sdn. Bhd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Plaxtron Industrial (M) Sdn. Bhd. in the registry?
The most recently registered devices listed for Plaxtron Industrial (M) Sdn. Bhd. include PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES.
Which FDA establishments are linked to Plaxtron Industrial (M) Sdn. Bhd.?
1 FDA establishment is linked to Plaxtron Industrial (M) Sdn. Bhd. in the registry; they are listed on the company page.